Evaluation Of The Efficacy And Safety Of Silodosin Vs. Tamsulosin And Placebo In The Treatment Of The Signs And Symptoms Of Benign Prostatic Hyperplasia. Multicentre, Randomised, Double-Blind, Controlled Trial With An Optional Long-Term Open-Label Extension Phase

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 1400

Inclusion Criteria

1.Male subjects aged 50 years or older;
2.Presence at Visits 2 (start of placebo run-in) and 3 (baseline), of an IPSS-1 score of =13;
3.Presence of less than 25% decrease of the IPSS-1 score between Visit 2 (start of placebo run-in) and Visit 3 (baseline);
4.Presence at Visits 2 (start of placebo run-in) and 3 (baseline), of bladder outlet obstruction, as defined by a Qmax (peak urine flow rate) between 4 and 15 mL/sec, with a minimum voided volume of =125 mL;
5.Presence of a satisfactory compliance to study medication (80-120%) at Visit 3 (baseline);
6.Able to comply with protocol procedures;
7.Able to give written informed consent before beginning any investigational procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Post void bladder residual volume of greater than 250 mL determined by ultrasound (not evaluated at Visit 2);
2.Intravesical obstruction from any cause other than BPH including vesicle neck contracture, Mullerian duct cysts, urethral stricture, valves, sclerosis, or other urethral tumor;
3.Bladder calculi;
4.History of, or current, neurogenic bladder and other conditions that may affect bladder function including detrusor-sphincter dyssynergia, spinal cord injury, brain or spinal cord tumors, multiple sclerosis, diabetic neuropathies or dementia;
5.History of any type of procedure in the past that is considered intervention for BPH or bladder neck obstruction including prior TURP, bladder neck resection, thermotherapy, laser therapy, TUNA therapy, or any other minimally invasive surgical therapies specifically designed for relief of BPH;
6.An active urinary tract infection, or a history of recurrent urinary tract infections defined as greater than 3 per year in the past two years;
7.Current prostatitis or a diagnosis of chronic prostatitis, or at Visit 1, a history of prostatitis within the past 3 months or recurrent prostatitis more than 3 times in the last year;
8.History of urinary retention, from a cause other than BPH, within the past 3 months;
9.History of prior prostate cancer, or prostate cancer as suspected by TRUS, DRE or clinical acumen. Subjects with a PSA greater than 10.0 ng/ml will be excluded. Subjects with a PSA between 4.0 and 10.0 should have prostate cancer ruled out to the satisfaction of the clinical Investigator with appropriate documentation of the physician’s assessment;
10.History of prior invasive bladder cancer. Subjects with superficial bladder cancers that have not recurred in 5 years are eligible for protocol inclusion;
11.Prior radiation to the pelvis regardless of the reason or dosage of radiation;
12.Bladder catheterization or bladder or prostate instrumentation within the past 30 days;
13.History of, or current significant postural hypotension, and/or have experienced significant postural hypotension upon initiating therapy with an a-blocker. Significant postural hypotension is defined as any one of the following observations upon standing: a) systolic blood pressure (SBP) decrease >30 mmHg, b) diastolic blood pressure (DBP) decrease >20 mmHg, c) heart rate (HR) decrease >20 bpm, d) symptoms upon change of position such as lightheadedness, fainting, blurring or temporary loss of vision, profound weakness, or syncope;
14.Clinical significant cardiovascular and cerebrovascular disease in the last 6 months including: angina pectoris (with the exception of chronic stable angina occurring with strenuous, rapid or prolonged exertion), severe CHF (NYHA classes III-IV, see section 17.5.), acute myocardial infarction, poorly controlled hypertension (sustained SBP>160, DBP>95 mmHg), endocarditis, cardiac arrhythmias, prosthetic heart valves, cardiac devices, stroke, transient ischemic attacks;
15.Poorly controlled diabetes (HbA1c >8%);
16.Renal insufficiency (serum creatinine >2.0 mg/dL);
17.Liver insufficiency (any LFT >2xULN);
18.Hematuria which has not been appropriately evaluated to determine safe subject participation;
19.Recurrent episodes of dizziness, vertigo, or loss of consciousness;
20.Pelvic surgery for malignancy or bowel resection;
21.History or current evidence of drug or alcohol abuse within the last 12 months;
22.History of allergy to a-blockers, or

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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